MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05860636001
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c501 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for four patient samples tested with the k electrode on a cobas 6000 c (501) module.An experienced user in the laboratory noticed the samples had critical values and quickly repeated testing on a second analyzer.The repeat results from the second analyzer were deemed correct and nurses were notified of the changes in results.The first sample initially resulted in a k value of 3.73 mmol/l and it repeated as 5.03 mmol/l.The second sample initially resulted in a k value of 3.04 mmol/l and it repeated as 4.19 mmol/l.The third sample initially resulted in a k value of 3.87 mmol/l and it repeated as 5.22 mmol/l.The fourth sample initially resulted in a k value of 3.06 mmol/l and it repeated as 4.07 mmol/l.
Additional Manufacturer Narrative
Quality controls recovered within range.There was no indication of a reagent performance issue.Upon review of the alarm trace, an abnormal ise preparation alarm and an abnormal ise calibration slope alarm were observed.The field service engineer found a contaminated system reagent.The customer replaced the reagents.The customer ran calibration and controls successfully.Patient correlation studies and precision studies were performed.Precision results were within expected ranges.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 6000 C (501) MODULE
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17560563
• Report Number: 1823260-2023-02667
• Device Sequence Number: 3600233
• Product Code: JJE
• UDI-Device Identifier: 08430215011539
• UDI-Public: 08430215011539
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05860636001
• Device Lot Number: #?
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown